Trial Outcomes & Findings for Pain and Loneliness (NCT NCT05455476)

NCT ID: NCT05455476

Last Updated: 2025-12-18

Results Overview

Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: baseline to 1-month post-treatment
• Results posted on: 2025-12-18

Participant Flow

Potential participants were recruited through a case finding procedure of VHA medical records.

The first 8 participants all received CBT for Loneliness after a baseline assessments. For the next 40 participants, participants in both conditions receive a baseline assessment and then were randomized to either CBT for Chronic Pain or CBT for Loneliness.

Participant milestones

Measure	CBT for Loneliness CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Overall Study STARTED	28	20
Overall Study COMPLETED	18	13
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain and Loneliness

Baseline characteristics by cohort

Measure	CBT for Loneliness n=25 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=20 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.	Total n=45 Participants Total of all reporting groups
Age, Continuous	54.6 Years STANDARD_DEVIATION 10.7 • n=47 Participants	52.8 Years STANDARD_DEVIATION 14.3 • n=41 Participants	53.8 Years STANDARD_DEVIATION 12.2 • n=88 Participants
Sex: Female, Male Female	5 Participants n=47 Participants	4 Participants n=41 Participants	9 Participants n=88 Participants
Sex: Female, Male Male	20 Participants n=47 Participants	16 Participants n=41 Participants	36 Participants n=88 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=47 Participants	0 Participants n=41 Participants	3 Participants n=88 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=47 Participants	20 Participants n=41 Participants	41 Participants n=88 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=47 Participants	2 Participants n=41 Participants	3 Participants n=88 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants
Race (NIH/OMB) Black or African American	6 Participants n=47 Participants	5 Participants n=41 Participants	11 Participants n=88 Participants
Race (NIH/OMB) White	16 Participants n=47 Participants	11 Participants n=41 Participants	27 Participants n=88 Participants
Race (NIH/OMB) More than one race	1 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants
UCLA Loneliness Scale	56.0 units on a scale STANDARD_DEVIATION 10.4 • n=47 Participants	56.8 units on a scale STANDARD_DEVIATION 10.3 • n=41 Participants	56.4 units on a scale STANDARD_DEVIATION 10.2 • n=88 Participants
Brief Pain Inventory-Pain Interference	52.5 units on a scale STANDARD_DEVIATION 13.2 • n=47 Participants	55.4 units on a scale STANDARD_DEVIATION 8.9 • n=41 Participants	53.8 units on a scale STANDARD_DEVIATION 11.3 • n=88 Participants
Tampa Scale of Kinesiophobia	45.8 units on a scale STANDARD_DEVIATION 7.9 • n=47 Participants	46.3 units on a scale STANDARD_DEVIATION 7.9 • n=41 Participants	46.0 units on a scale STANDARD_DEVIATION 7.7 • n=88 Participants
PROMIS Depression	10.8 units on a scale STANDARD_DEVIATION 4.3 • n=47 Participants	13.1 units on a scale STANDARD_DEVIATION 3.6 • n=41 Participants	11.8 units on a scale STANDARD_DEVIATION 4.1 • n=88 Participants
PROMIS Anxiety	10.9 units on a scale STANDARD_DEVIATION 4.1 • n=47 Participants	13.0 units on a scale STANDARD_DEVIATION 3.0 • n=41 Participants	11.8 units on a scale STANDARD_DEVIATION 3.7 • n=88 Participants
Pain Catastrophizing Scale	31.9 units on a scale STANDARD_DEVIATION 11.5 • n=47 Participants	30.2 units on a scale STANDARD_DEVIATION 9.0 • n=41 Participants	31.2 units on a scale STANDARD_DEVIATION 10.3 • n=88 Participants

PRIMARY outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.

Outcome measures

Measure	CBT for Loneliness n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=13 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Loneliness	-6.6 score on a scale Standard Deviation 7.2	-2.5 score on a scale Standard Deviation 9.1

PRIMARY outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

Pain interference will be measured using the Brief Pain Inventory Pain Interference subscale. The pain interference subscale comprises 7 items assessing the extent to which pain interferes with various aspects of one's life (e.g., mood, sleep, daily activities) with scores ranging from 0 to 70. Higher scores represent greater pain-related interference in activity.

Outcome measures

Measure	CBT for Loneliness n=11 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Pain Interference	-2.4 score of a scale Standard Deviation 2.5	-0.5 score of a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37.

Outcome measures

Measure	CBT for Loneliness n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=13 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Social Interactions	-0.33 score on scale Standard Deviation 2.5	0.46 score on scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

Fear of movement due to pain will be measured using the Tampa Scale of Kinesiophobia. The scores range from 17-68 with higher scores indicating worse outcome.

Outcome measures

Measure	CBT for Loneliness n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=13 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Fear of Pain	-3.17 score on a scale Standard Deviation 6.0	-0.54 score on a scale Standard Deviation 5.9

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Outcome measures

Measure	CBT for Loneliness n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=13 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Depression	-3.25 score on a scale Standard Deviation 4.1	-0.3 score on a scale Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Outcome measures

Measure	CBT for Loneliness n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=13 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Anxiety	-3.7 score on a scale Standard Deviation 3.8	-0.6 score on a scale Standard Deviation 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 1-month post-treatment

Population: Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up.

The Pain Catastrophizing Scale (PCS) is a 13-item measure, with each item rated on a 5-point rating scale (0 = "Not at all" to 4 = "All the time"). The measure is divided into three subscales: magnification, rumination, and helplessness. Scores range from 0 to 52 with higher scores indicate greater pain catastrophizing.

Outcome measures

Measure	CBT for Loneliness n=12 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=13 Participants CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Mean Change in Pain Catastrophizing	-7.1 score on a scale Standard Deviation 10.1	-2.3 score on a scale Standard Deviation 12.4

Adverse Events

CBT for Loneliness

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

CBT for Chronic Pain

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	CBT for Loneliness n=28 participants at risk CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=20 participants at risk CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Respiratory, thoracic and mediastinal disorders Hospital admission - COPD	3.6% 1/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Nervous system disorders Hospital admission - falls	3.6% 1/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Nervous system disorders Hospital admission - Nerve pain	3.6% 1/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Psychiatric disorders Hospital admission - suicidal ideation	0.00% 0/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	5.0% 1/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Metabolism and nutrition disorders Hospital admission - hypokalemia	0.00% 0/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	5.0% 1/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)

Other adverse events

Measure	CBT for Loneliness n=28 participants at risk CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.	CBT for Chronic Pain n=20 participants at risk CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Musculoskeletal and connective tissue disorders Emergency department visit - pain	3.6% 1/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	5.0% 1/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Nervous system disorders Emergency department visit - head pain	0.00% 0/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	10.0% 2/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Gastrointestinal disorders Emergency department visit - nausea, chest pain	0.00% 0/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	5.0% 1/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Social circumstances Psychological distress	10.7% 3/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	10.0% 2/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Respiratory, thoracic and mediastinal disorders Emergency department visit - pneumonia	3.6% 1/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Nervous system disorders Emergency department - fall	7.1% 2/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Reproductive system and breast disorders Emergency department visit - erectile dysfunction	0.00% 0/28 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	5.0% 1/20 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)

Additional Information

Lisham Ashrafioun

VA Center of Excellence for Suicide Prevention

Phone: 585-430-2026

Email: Lisham.ashrafioun@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place